22nd Century Provided with Written Feedback from FDA on the Company’s
Modified Risk Tobacco Product Application

February 28, 2017 06:59 AM Eastern Standard Time

CLARENCE, N.Y.--(BUSINESS WIRE)--22nd Century Group, Inc. (NYSE MKT: XXII),
a plant biotechnology company that is focused on reducing the harm
caused by smoking, announced today that the Company has received written
feedback from the Center for Tobacco Products (CTP) of the U.S. Food and
Drug Administration (FDA) on the Company’s “BRAND A” Modified
Risk Tobacco Product (MRTP) application. 22nd Century received feedback
from the FDA in conjunction with the Company’s withdrawal of its MRTP
application in order to file an even more expansive and robust MRTP
application that will include additional scientific data and information
from already completed clinical studies on the Company’s Very Low
Nicotine (VLN) tobacco cigarettes.

The MRTP application for BRAND A requests that CTP allow 22nd
Century to be able to state as truthful and accurate in BRAND A
packaging and advertising that the Company’s proprietary VLN cigarettes
reduce smokers’ exposure to nicotine because the Company’s proprietary
VLN tobacco contains 95% less nicotine than the tobacco contained in
conventional tobacco cigarettes. The Company’s keystone technology is
its ability to grow proprietary VLN tobacco that contains up to 95% less
nicotine than conventional tobacco plants.

In response to the CTP’s clarifying guidance, the Company intends to
bifurcate its combined MRTP application into a separate Premarket
Tobacco Product (PMT) application and a separate MRTP application for BRAND
A to enjoy the benefit of the CTP/FDA’s shorter review period for
PMT applications as compared to MRTP applications. In response to the
FDA’s request, 22nd Century’s revised MRTP application will also include
additional scientific data and information from already completed
clinical studies on the Company’s VLN tobacco cigarettes. The Company
anticipates filing its more expansive and robust PMT application and
MRTP application later this year.

“We are encouraged by CTP/FDA’s feedback on our MRTP application and we
look forward to working cooperatively with the FDA to obtain the
Agency’s approval to market BRAND A as an over-the-counter,
modified risk tobacco product that significantly reduces smokers’
exposure to nicotine,” explained Henry Sicignano, III, President and CEO
of 22nd Century Group.

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology
which allows it to increase or decrease the level of nicotine in tobacco
plants and the level of cannabinoids in cannabis plants through genetic
engineering and plant breeding. The Company’s primary mission is to
reduce the harm caused by smoking. 22nd Century currently owns or
exclusively controls more than 200 issued patents and more than 50
pending patent applications around the world. Visit www.xxiicentury.com
for more information.

Cautionary Note Regarding Forward-Looking Statements:This
press release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc., its
directors or its officers with respect to the contents of this press
release, including but not limited to our future revenue expectations.
The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,”
“believe,” “intend” and similar expressions and variations thereof are
intended to identify forward-looking statements. We cannot guarantee
future results, levels of activity or performance. You should not place
undue reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should be
considered with any written or oral forward-looking statements that we
may issue in the future. Except as required by applicable law, including
the securities laws of the United States, we do not intend to update any
of the forward-looking statements to conform these statements to reflect
actual results, later events or circumstances, or to reflect the
occurrence of unanticipated events. You should carefully review and
consider the various disclosures made by us in our annual report on Form
10-K for the fiscal year ended December 31, 2015, filed on February 18,
2016, including the section entitled “Risk Factors,” and our other
reports filed with the U.S Securities and Exchange Commission which
attempt to advise interested parties of the risks and factors that may
affect our business, financial condition, results of operation and cash
flows. If one or more of these risks or uncertainties materialize, or if
the underlying assumptions prove incorrect, our actual results may vary
materially from those expected or projected.